FDA.reportPublic FDA data

Lidozen Patch

Product NDC
71574-905
11-digit product format
715740905
Labeler code
71574
Product ID
71574-905_fa3635ec-4a51-4f90-bce0-6c98e7b450f5
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE, MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Village Pharma LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-01
Substance
LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength
40; 10 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Lidozen Patch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g
MENTHOL, UNSPECIFIED FORM10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1249758Internal RxNorm lookup
2201504Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d0ec7d25-ad58-46f2-b3b3-f13b4648b0b6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71574-905-05Lidozen Patch1 g in 1 PATCHPATCH13
71574-905-05Lidozen Patch5 in 1 POUCHPATCH53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71574-905-05EA - Each71574-905b8a8a20a-b5ce-4b1a-9b27-77ca28be07d912023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71574-905LIDOZEN PATCH (LIDOCAINE, MENTHOL) PATCH [VILLAGE PHARMA LLC]2Current NDC, Legacy NDC, 2 package rows20231201_d0ec7d25-ad58-46f2-b3b3-f13b4648b0b6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 22 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited06cb845c-cc53-1f1d-e063-6394a90a8c012026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0ef7c3aa-94a3-9fe9-e063-6394a90ab13d2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5071f145-49f7-0855-e063-6394a90a8f262026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09260c31-56a3-07aa-e063-6394a90a95fd2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5072ad57-9fa7-ddba-e063-6394a90a319b2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09235f26-2262-6ca2-e063-6394a90ad8f12026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0f333f93-bec6-72d5-e063-6394a90a4e3f2026-04-27WarningsExact identifier
application number: M017
HIP PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.502f1f9e-8552-ca7b-e063-6394a90a7c532026-04-24WarningsExact identifier
application number: M017
SOMBRA WARM THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.de78dba9-53b3-4dbd-9dd2-6a692378da342026-04-24WarningsExact identifier
application number: M017
Rite Aid Itch ReliefDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Rite Aide285df43-317c-d862-e053-2a95a90acdce2026-04-23WarningsExact identifier
application number: M017
FixMySkin Healing Balm UnflavoredHYDROCORTISONELovely Skin, Inc.9ff8db07-ad6d-4865-a534-94bd8312957e2026-04-23WarningsExact identifier
application number: M017
DCH Labs CortisoneHYDROCORTISONE 1%Derma Care Research Labs5025f53a-02e0-0f6a-e063-6394a90adbbf2026-04-23WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEPreferred Pharmaceuticals Inc.e0f46445-64c5-4f5d-90b0-3fa07ed7d1b42026-04-22WarningsExact identifier
application number: M017
Dr. Carrasco Pain ReliefMENTHOLCarrasco Enterprises, Inc.befa8526-f468-428e-a829-422c2ea486122026-04-21WarningsExact identifier
application number: M017
HealthWise Feminine Anti-itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare4ff88b9e-5869-a1cb-e063-6294a90a87b72026-04-21WarningsExact identifier
application number: M017
SOMBRA COOL THERAPYMENTHOLSOMBRA COSMETICS INC.87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca32026-04-21WarningsExact identifier
application number: M017
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.c4c86a8f-1d57-49d2-a65f-acb0dccf2f872026-04-21WarningsExact identifier
application number: M017
KOXUO Arnica Bruise CreamARNICA BRUISE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5003bf83-fa01-b01a-e063-6294a90ad37f2026-04-21WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Arnica and 4% LidocaineKT PAIN RELIEF CREAM MAGNESIUM WITH ARNICA AND 4% LIDOCAINE ROLLONClarion Brands LLC4f82993c-ebc4-5787-e063-6294a90a12d62026-04-20WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Cooling 5% MentholKT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOLClarion Brands LLC4fe64056-f3c6-bc76-e063-6294a90a7e622026-04-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSNd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
2201504Lidozen 4 % / 1 % Medicated PatchPSNd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
2201504lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [Lidozen]SBDd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCDd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
1249758lidocaine 4 % / menthol 1 % Medicated PatchSYd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
2201504Lidozen (lidocaine 4 % / menthol 1 % ) Medicated PatchSYd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSNc0df4b8b-2679-4652-9144-a8db916a186b2
2201504Lidozen 4 % / 1 % Medicated PatchPSNc0df4b8b-2679-4652-9144-a8db916a186b2
2201504lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [Lidozen]SBDc0df4b8b-2679-4652-9144-a8db916a186b2
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCDc0df4b8b-2679-4652-9144-a8db916a186b2
1249758lidocaine 4 % / menthol 1 % Medicated PatchSYc0df4b8b-2679-4652-9144-a8db916a186b2
2201504Lidozen (lidocaine 4 % / menthol 1 % ) Medicated PatchSYc0df4b8b-2679-4652-9144-a8db916a186b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71574-905-05715740905055 PATCH in 1 POUCH (71574-905-05) / 1 g in 1 PATCH5 patch2022-09-010000-00-00NoNoCurrent